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Bupropion hydrobromide - Generic Drug Details

What are the generic sources for bupropion hydrobromide and what is the scope of bupropion hydrobromide freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for bupropion hydrobromide

US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	38
Suppliers / Packagers:	1
Bulk Api Vendors:	7
Clinical Trials:	3
Patent Applications:	67
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupropion hydrobromide
DailyMed Link:	bupropion hydrobromide at DailyMed

Pharmacology for bupropion hydrobromide

Drug Class	Aminoketone
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Synonyms for bupropion hydrobromide

2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide
905818-69-1
AK-75761
AKOS015917698
Aplenzin
Aplenzin ER
bupropion HBr
Bupropion hydrobromide (USAN)
Bupropion hydrobromide [USAN]
CHEMBL1201735
D07938
I14-9201
SCHEMBL636116
WSTCENNATOVXKQ-UHFFFAOYSA-N

Tentative approvals for BUPROPION HYDROBROMIDE

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	522MG	TABLET, EXTENDED RELEASE; ORAL
➤ Sign Up	➤ Sign Up	174MG	TABLET, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for bupropion hydrobromide

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-002	Apr 23, 2008		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-003	Apr 23, 2008		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Valeant Pharms North	APLENZIN	bupropion hydrobromide	TABLET, EXTENDED RELEASE;ORAL	022108-001	Apr 23, 2008		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

International Patents for bupropion hydrobromide

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Country	Document Number	Estimated Expiration
China	101784266	➤ Sign Up
Australia	2008285660	➤ Sign Up
Costa Rica	9609	➤ Sign Up
New Zealand	561375	➤ Sign Up
Mexico	2010001449	➤ Sign Up
World Intellectual Property Organization (WIPO)	2007002597	➤ Sign Up
South Africa	201003036	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for bupropion hydrobromide

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2000 00018	Denmark	➤ Sign Up	PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2017 00062	Denmark	➤ Sign Up	PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2017000109	Germany	➤ Sign Up	PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
C/GB00/019	United Kingdom	➤ Sign Up	PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
0918	Netherlands	➤ Sign Up	PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
/2000	Austria	➤ Sign Up	PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description